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Pharma giants sign COVID-19 vaccine safety pledge

Nine leading US and European vaccine developers have signed a pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines.

The CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck (known as MSD outside the United States and Canada), Moderna, Novavax, Pfizer and Sanofi have announced a what they call, a “historic pledge”, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.

The vaccine makers said they will “stand with science”, at a time when the world is looking to science – in particular to a vaccine – to help bring us to the end of the pandemic.

Help ensure public confidence

The companies pledge to always make the safety and well-being of vaccinated individuals our top priority, continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes, only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA, and to work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved,” stated the nine CEOs.

A new sense of openness

In an interview in the latest issue of our magazine (No 03 2020) Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer Inc., said that he hopes that the global collaborations born out of desperation during the pandemic will not end when a COVID-19 cure and vaccine are found.

“The pandemic has created a new sense of openness and trust to share early data and novel ideas. We’ve opened doors for one another, and I believe the way we are working now will carry forward into our future.”

“Our industry peers, the other pharmaceutical and biotechnology companies, have come together like never before. We’re acutely aware that we are all on the same side, and COVID-19 and other diseases are the enemies. The pandemic has created a new sense of openness and trust to share early data and novel ideas. We’ve opened doors for one another, and I believe the way we are working now will carry forward into our future,” he said to Nordic Life Science.

 

Mikael Dolsten

Mikael Dolsten, CSO, Pfizer

Pfizer is currently preparing for potential human COVID-19 patient studies for IV administration, provided pre-clinical confirmatory studies are successful.

Safety is the main focus

The nine vaccine makers say they will uphold “high ethical standards,” suggesting they won’t seek premature government approval for any COVID-19 vaccines they develop.

The statement is perhaps particularly important in the US, where President Trump has pushed for a vaccine before the presidential election.

“I love the fact that the nine big vaccine manufacturers today said they would not do anything premature — I think there’s enormous pressure to do something premature.”

“There’s absolutely a desperate need for this vaccine,” said Dr. Judith Feinberg, the vice chairwoman for research in medicine at West Virginia University in Morgantown to the New York Times. “I love the fact that the nine big vaccine manufacturers today said they would not do anything premature — I think there’s enormous pressure to do something premature.”

All nine CEOs signed the following pledge

“We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles. The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.”

Image: BNT162 vial, BioNTech’s COVID-19 vaccine candidate